TL 9000 Quality System
Requirements
Book One
Copyright 1999 Quality Excellence for Suppliers of Telecommunications Forum
For further information, refer to the QuEST Forum Web page at: www.questforum.org
TL 9000 is a registered trademark of the Quality for Excellence for Suppliers of Telecommunications Forum.
Sections of this document contain copyrighted material from a variety of sources, these sources are identified in the Bibliography of this Handbook.
The text highlighted in the boxes throughout this document is a verbatim reproduction of ISO 9001:1994. This text is copyrighted by the International Organization Standardization. Not for resale. No part of this standard may be copied or reproduced in any form, including
an electronic retrieval system, without the prior written permission of the
American National Standards Institute, Inc., 11 West 42nd Street, New York, NY 10036, which holds reproduction rights in the United States.”
Foreword
The Telecommunications industry service providers and their suppliers are committed to meeting the expectations of their customers. Each has strived individually to accomplish this for many years. Most observers of the
telecommunications industry would agree that very good progress has been made in the twentieth century. There is also a strong need, however, for even greater progress in the years ahead, and the challenge is how to make this a reality. The Quality Excellence for Suppliers of Telecommunications Forum includes most of the major service providers and their suppliers. We have joined forces in a remarkably cooperative and constructive spirit and created the TL 9000 Handbooks. Our goal from the beginning has been to develop a consistent set of quality system requirements and metrics when implemented will help provide telecommunications users with faster, better and more cost-effective services.
The TL 9000 Quality System Requirements and TL 9000 Quality System Metrics Handbooks were produced by having the best people from service providers and suppliers working together toward a common goal. The handbooks include an agreed-upon set of quality system requirements and metrics that were drawn from the best features of similar management system standards and the most effective quality practices currently being used in the telecommunications industry.
As we in the telecommunications industry take steps to ensure that the quality of our services keeps pace with changing technological opportunities in the twenty-first century, all telecommunications users worldwide will benefit from ever improving telecommunications products.
Steve Welch Krish Prabhu
Preface
The Quality Excellence for Suppliers of Telecommunications Leadership Forum (“QuEST Forum”) was founded to foster continued improvements to the quality and reliability of telecommunications service. The founders took the critical initial step of establishing a common set of quality system requirements and metrics by creating the TL 9000 Quality System Requirements Handbook and the TL 9000 Quality
System Metrics Handbook. These handbooks are the result of a cooperative effort
among members of the telecommunications industry.
The work of the QuEST Forum yields benefits to service providers, their subscribers, and their suppliers. Membership is composed of members of the
telecommunications industry. Members fund and participate in the Forum, have defined voting rights and are expected to contribute to the work of the Forum. Members vote on adoption of the TL 9000 structure, content, administration and other questions coming before the Forum.
The Forum establishes and maintains a common set of quality system requirements and metrics built upon currently used industry standards, including the ISO 9001 International Standard. The requirements promote consistency, efficiency, and improve customer satisfaction. They also enable suppliers to improve quality and reliability, reduce costs and increase competitiveness.
Acknowledgements
Many members of the Quality Excellence for Suppliers of Telecommunications Forum (“QuEST Forum”) contributed to the development of theTL 9000
Handbooks. These handbooks were truly a team effort by the experts that make
up the Forum’s membership. The following individuals participated in the development of this set of TL 9000 Quality System Requirements as representatives of their companies.
I would like to thank the members of the QuEST Forum and the volunteer registrars for their dedication and cooperation in creating the TL 9000
Handbooks, and the Quality Excellence for Suppliers of Telecommunications Forum.
Jim McDonnell
QuEST Forum Project Director
Daniel Avery Symmetricom
Galen Aycock Bell Atlantic
Beth Baker AIAG
Chanden Banerjee Newbridge Networks
Bret Barclay RELTEC Corp.
Jim Barke ADC Telecommunications
Alan Beaudry Bell Atlantic Gary Bishop Sumitomo Electric Dave Bisone Lucent Technologies
Reg Blake BSI
Terry Blok Unisys
James Bossert Nokia Mobile Phones Michele Boulanger Motorola
Paula Brackman Telcordia Technologies Bob Brigham Telcordia Technologies Joan Brough-Kerrebyn SCC
Jack Burgen MCI WorldCom
Larry Busch Lucent Technologies
Jerry Cates Siecor
Bud Cuthbert QMI
Duke Dahmen Tellabs
Ashok Dandekar Fujitsu
Paula DeCarlo Pulsecom
E. deVries Telkom South Africa Thierno Diallo 3M Telecom Systems
Bob Dietz RELTEC Corp.
Tim Dinneen Sprint North Supply
Amy Dixon Lucent Technologies
Allen Dobney Cisco Systems
Kim Dobson Motorola
Joe Doro Charles Industries
Jean-Normand Drouin Bell Canada Jim Dumouchelle Nortel Networks
Greg Feldman Motorola
Mehmet Ficici QUASAR
Paul Fortlage RAB
Tilman Foust Hekimian Laboratories
Mike Gericke BellSouth
Joe Gibbs Lucent Technologies
Frank Gray, Jr. Motorola
Robert Gray AT&T
Glen Groenewold Motorola Dennis Grousosky Graybar Electric
Jack Growe CTDI
Steve Hackett SBC
Jeff Harpe Nortel Networks
Andy Hart BroadBand Technologies
Debbie Hearn Telcordia Technologies
Rich Helmuth GTE
Ron Hershberger Ericsson
Gene Hutchison SBC
Steve Jackson Westell
Ari Jain Lucent Technologies
Alka Jarvis Cisco Systems
John Jennings RELTEC Corp
Mike Jennings Pulsecom
Pete Johnson Graybar Electric John J. Johnson IV Pulsecom
Wally Jubran Pirelli
Tim Kalisz Telcordia Technologies Mary-Ruth Keough Alcatel
Duane Knecht CTDI
Ken Koffman Siemens
Jeff Lanham Sprint
Gene Lassiter Nortel Networks Sandy Liebesman Lucent Technologies
Matt Lindsay Tellabs
Ron Luttrull Alcatel
Richard Lycette Newbridge Networks Nick Magro Underwriters Laboratories
Dick Malcangio Qualcomm
Henry Malec 3COM
Michael Manning Newbridge Networks
Sue Maxwell Excel Switching
Tama McBride Motorola
Jim McDonnell SBC
Greg Miller Motorola
Paul Miller Siemens
Ken Molenilli RELTEC Corp.
Mark Moore Alcatel
Art Morrical Lucent Technologies
Rosemarie Moskow SBC
Pat Muirragui Siemens
Tom Murrell Pirelli
John Nolan US West
William J. Novak Lucent Technologies Charles O’Donnell ADTRAN
Robert Oakley Nortel Networks
Richard Pierrie Nortel Networks
Bill Poliseo BVQI
Tex Prater BellSouth
Richard Pratt Ericsson
Jodie Pryor AT&T
Judy Przekop Ameritech
Misha Ptak Pulsecom
Mustafa Pulat Lucent Technologies George Raemore Motorola
Soundar Rajan PairGain Technologies
Gary Reams NEC America
Joel Reece Siecor
Bridget Rees NEC America
Jerry Reichert RELTEC Corp.
Donna Reinsch RELTEC Corp.
John Rosenow MCI WorldCom
Gwynne Roshon-Larsen Cisco Systems Marty Rudnick Lucent Technologies John Russell Telcordia Technologies
H. Pierre Salle KEMA
Mike Samocki Teltrend
Victor Sandoval Ericsson Donna Schilling Symmetricom Tom Scurlock Lucent Technologies
Darryl Seeley RELTEC Corp.
Chris Shillito Eagle Registrations David Siebrasse Antec
Doug Smith Ericsson
John Smith Tellabs
John Snarr RELTEC Corp.
Phil Snow Alcatel
Roy Stephens PairGain Technologies
Rob Stewart Cisco Systems
Olga Striltschuk Motorola
Steve Stroup SBC
Joel Sullivan BellSouth
Greg Swan BVQI
Bill Taylor Antec
Joe Taylor Tellabs
Steve Thoma GTE
Don Topper Alcatel
Anthony Vitucci Hekimian
Vicki Walker Tellabs
John Walz Lucent Technologies
Tom Wanek RELTEC Corp.
Rich Watts AT&T
Rick Werth SBC
Randal Whorton ADTRAN
Don Wilford US WEST
John Wronka Lucent Technologies Leslie Wolf Telcordia Technologies
Table of Contents
SECTION 1 - INTRODUCTION...1-1
SECTION 2 - STRUCTURE ...2-1
SECTION 3 - TL 9000 ADMINISTRATION ...3-1
SECTION 4 - QUALITY SYSTEM REQUIREMENTS...4-1
MANAGEMENT RESPONSIBILITY - ELEMENT 4.1 ...4-1 QUALITY SYSTEM - ELEMENT 4.2...4-3 CONTRACT REVIEW - ELEMENT 4.3 ...4-6 DESIGN CONTROL - ELEMENT 4.4 ...4-8 DOCUMENT AND DATA CONTROL - ELEMENT 4.5... 4-15 PURCHASING - ELEMENT 4.6 ... 4-17 CONTROL OF CUSTOMER-SUPPLIED PRODUCT - ELEMENT 4.7 ... 4-19 PRODUCT IDENTIFICATION AND TRACEABILITY - ELEMENT 4.8... 4-20 PROCESS CONTROL - ELEMENT 4.9... 4-21 INSPECTION AND TESTING - ELEMENT 4.10 ... 4-23 CONTROL OF INSPECTION, MEASURING, AND TEST EQUIPMENT - ELEMENT 4.11... 4-26 INSPECTION AND TEST STATUS - ELEMENT 4.12 ... 4-28 CONTROL OF NONCONFORMING PRODUCT - ELEMENT 4.13 ... 4-29 CORRECTIVE AND PREVENTIVE ACTION -ELEMENT 4.14 ... 4-30 HANDLING, STORAGE, PACKAGING, PRESERVATION & DELIVERY - ELEMENT 4.15 .... 4-32 CONTROL OF QUALITY RECORDS - ELEMENT 4.16... 4-34 INTERNAL QUALITY AUDITS - ELEMENT 4.17 ... 4-35 TRAINING - ELEMENT 4.18... 4-36 SERVICING - ELEMENT 4.19... 4-37 STATISTICAL TECHNIQUES - ELEMENT 4.20 ... 4-39 QUALITY IMPROVEMENT AND CUSTOMER SATISFACTION - ELEMENT 4.21... 4-40
APPENDIX A : TL 9000 ACCREDITATION BODY IMPLEMENTATION
REQUIREMENTS ... A-1
APPENDIX B : CODE OF PRACTICE FOR TL 9000 REGISTRARS ... B-1
APPENDIX C : REGISTRATION PROCEDURES ... C-1
APPENDIX D : MIGRATION PATH AND AUDIT DAYS... D-1
APPENDIX E : ALTERNATIVE METHOD FOR MAINTAINING TL 9000
CERTIFICATION/REGISTRATION... E-1
BIBLIOGRAPHY AND FOOTNOTE REFERENCE ... 1
List of Figures
FIGURE 1: THE TL 9000 MODEL ...2-1
FIGURE 2: ALTERNATIVE ACCREDITATION PROCESS... E-1
FIGURE 3: INTERNAL SUPPLIER AUDITS ... E-2
List of Tables
TABLE 1: TYPE OF CERTIFICATION ...3-1
Section 1 – Introduction
The TL 9000 Handbooks (TL 9000 Quality System Requirements and the TL 9000 Quality System Metrics) are designed specifically for the telecommunications industry to document the industry’s quality system requirements and metrics. The TL 9000 Quality System Requirements Handbook consists of four (4) major sections with appendices. It establishes a common set of quality system
requirements for suppliers of telecommunications products: hardware, software or services. The requirements are built upon existing industry standards, including ISO 9001. The TL 9000 Quality System Metrics Handbook defines a minimum set of performance metrics and cost and quality indicators to measure progress and evaluate results of quality system implementation.
The goals of TL 9000 are to:
• Foster quality systems that effectively and efficiently protect the integrity and use of telecommunications products: hardware, software or services;
• Establish and maintain a common set of quality system requirements;
• Reduce the number of telecommunications quality system standards;
• Define effective cost and performance-based metrics to guide progress and evaluate results of quality system implementation;
• Drive continuous improvement;
• Enhance customer-supplier relationships; and
• Leverage industry conformity assessment processes.
The purpose of TL 9000 is to define the telecommunications quality system requirements for the design, development, production, delivery, installation, and maintenance of products: hardware, software or services. Included in TL 9000 are cost and performance-based metrics that measure reliability and quality
performance of these products.
Telecommunications service providers, their subscribers, and all customers will benefit as a result of implementing TL 9000.
Expected benefits are:
• Continuous improvement of service to subscribers;
• Enhanced customer-supplier relationships;
• Standardization of quality system requirements;
• Efficient management of external audits and site visits;
• Uniform cost and performance-based metrics;
•
1.2 Purpose 1.1 Goals
1.3 Benefits of Implementation
• Industry benchmarks for TL 9000 metrics.
The QuEST Forum maintains compatibility with other sets of requirements and standards. TL 9000 provides a telecommunications-specific set of requirements built upon an ISO 9001:1994 framework. See the Bibliography for the standards and requirements that were considered during the development of TL 9000.
Characteristics of the TL 9000 relationship to other requirements are:
• TL 9000 includes ISO 9001:1994; any future revisions to ISO 9001 will be incorporated;
• Conformance to TL 9000 constitutes conformance to corresponding ISO 9001 requirements; and
• It is the intent of the QuEST Forum that conformance to TL 9000 will eliminate the need for conformance to other telecommunications quality management standards.
TL 9000 requires a supplier to establish and maintain a process for communicating with its customer base; refer to Section 4, requirement 4.21.2. Also see the
Appendix, “Guidance for Customer-Supplier Communications.”
The QuEST Forum is responsible for the development, publication, distribution, and maintenance of the TL 9000 Handbooks that are publicly available. Change requests for the handbooks, following their initial publication, are to be submitted to the Forum Administrator. Any user of the handbooks may submit change requests. Change requests will be forwarded to the appropriate Handbook section chairperson by the Forum Administrator, and will be considered for the next revision.
Final approval of all changes to TL 9000 will be by vote of the QuEST Forum voting members in accordance with the Forum’s bylaws. Re-issue of the TL 9000
Handbooks will be determined by the Forum, but not to exceed five (5) years following the last issue date. When the Forum determines there are issues in the standard that could impact third party registration, then addenda or similar
communication mechanisms will be employed to inform the industry of corrections and updates to the standard.
1.4 Relationship to ISO 9001 and Other Requirements 1.6 Developing and Maintaining the Handbook(s) 1.5 Customer-Supplier Communication
Section 2 - Structure
TL 9000 is structured in layers (See Figure 1):
• International Standard - ISO 9001
• Common TL 9000 Requirements
• Hardware, Software and Services Specific Quality System Requirements
• Common TL 9000 Metrics
• Hardware, Software and Services Specific Quality System Metrics
The TL 9000 Model
The TL 9000 Model
International Standard ISO 9001
Common TL 9000 Requirements
Hardware Specific
Requirements
Software Specific
Requirements
Services Specific
Requirements
Hardware
Metrics
Software
Metrics
Services
Metrics
T
L
9
0
0
0
Common TL 9000 Metrics
Figure 1. The TL 9000 Model
2.1 Overall Structure
ISO 9001:1994 Clause 4 has been adopted as the foundation for this Handbook. All references to ISO 9001 are printed in Italics and enclosed in a text box. For the
purposes of TL 9000, the term “product,” as used within the ISO 9000 series, includes hardware, software or services.
Interpretations and supplemental quality system requirements have been harmonized and are printed in plain text.
The QuEST Forum retains full control over the content except for material that is copyrighted by others.
Section 4 "Quality System Requirements" contains the auditable requirements. Each of the TL 9000 specific requirements is tagged with an identifier to define the related scope of that requirement. The following table describes each of these identifiers:
Code Description Example
C Common (H, S & V) 4.4.4.C.1
H Hardware Only 4.4.4.H.1
HS Hardware & Software 4.4.4.HS.1
HV Hardware & Services 4.4.4.HV.1
S Software Only 4.4.4.S.1
V Services Only 4.4.4.V.1
VS Services & Software 4.4.4.VS.1
The use of terms in TL 9000 such as shall, should, may, and can follow the standard ISO definitions. The word shall indicates mandatory requirements. The word should indicates a preferred approach. Suppliers choosing other approaches must be able to show that their approach meets the intent of TL 9000. Where the words typical and examples are used, an appropriate alternative for the particular commodity or process should be chosen.
Paragraphs marked NOTE are for guidance and are not subject to audit. NOTES taken directly from ISO 9001 are numbered, and these numbers begin at 5 because only notes from Section 4 are taken from ISO 9001. NOTES 1-4 are not included because they are part of ISO 9001 Section 1-3. NOTES X (alphabetical) are notes that were added by the Forum.
Endnotes denoted by [x] represent bibliography source material that is not auditable.
2.2 Structure of Sections
The International Standard, ISO 8402:1994, Quality Management and Quality
Assurance — Vocabulary, contains standard definitions of terms used within this
handbook. These definitions are considered part of the provisions throughout all sections of this handbook.
Section 3 - TL 9000 Administration
The scope of a registration may apply to hardware, software, services or any combination thereof. The TL 9000 registration may include an entire company, an organizational unit, a facility(s), or a limited, defined product line as mutually agreed by the supplier and the registrar. The scope of TL 9000 registration will be clearly defined within the certificate.
TL 9000 supports three distinct certifications:
TL 9000-HW Hardware
TL 9000-SW Software
TL 9000-SC Services
A company may request registration to any of the above specialty areas or any combination thereof. For example, registration of a quality system specifically for Hardware (TL 9000-HW) requires that only the requirements with identifiers Hardware (H) be addressed in addition to the ISO 9001 and Common (C) identified requirements as well as Common and Hardware Metrics.
Table 1 identifies the type of certification and the required sections in the TL 9000 Handbooks (as denoted by "X").
Type of Certification TL 9000 Section ISO (Italics) Common Reqs. (C) Hardware Reqs. (H) Software Reqs. (S) Services Reqs. (V) Common Metrics Hardware Metrics Software Metrics Services Metrics Hardware only X X X X X Software only X X X X X Services only X X X X X
Table 1: Type of Certification
Any combination of certification types also requires conformance to their appropriate sections in the handbooks.
The method by which a supplier demonstrates conformance to the TL 9000 requirements is by successfully completing a third-party registration audit by an accredited TL 9000 registrar. For each three (3)-year interval, 100% of the scope of the entity being registered and the TL 9000 elements shall be assessed. For companies with mature quality systems, there are also alternative methods for maintaining registration. These methods include third-party registrars, but leverage certain existing elements of the supplier’s quality system to reduce cost and add value. In order to use the alternative method, eligibility criteria must be satisfied.
3.1 Registration Options
Guidelines for alternative methods for maintaining registration are published by the International Accreditation Forum (IAF). The IAF is an international consortium of accreditation bodies. Typically, a supplier wishing to maintain registration to TL 9000 via an alternative method would first begin working with a third-party registrar to determine eligibility. See the Appendix, “Alternative Method for Maintaining TL 9000 Certification/Registration.”
The QuEST Forum recognizes the achievement of existing quality system efforts. These efforts will be leveraged in the migration path to TL 9000.
Currently implemented quality systems and maturity levels are considered in the transition to TL 9000. A matrix defining the steps needed to come into compliance with the standard are included in the Appendix titled “Migration Path and Audit Days.” Various schemes are described along with recommended industry compliance time frames.
Members of the telecommunications industry certified by an accredited TL 9000 registrar may publicize the fact that their quality management systems have been approved for the scope identified on their registration certificates. Suppliers may not state or imply that their products are registered or certified to TL 9000. The specific rules for publicizing TL 9000 registration are as follows:
• The registered unit is entitled to use certification marks on letterheads, brochures and other promotional material;
• The mark shall not be used on manufactured product, packaging, trade samples, or other statements of Product Compliance;
• The mark shall only be used to imply that certification exists as defined in the scope of approvals stated on the certificate;
• References to the TL 9000 registration shall only apply to the scope as defined on the certificate;
• The mark shall not be used on flags, buildings, or vehicles;
• The supplier shall not publish or circulate an image of a product with TL 9000 stamped on or across it;
• In the event that certification ceases to be valid for any reason, the certificate holder shall immediately discontinue all use and distribution of any letterheads; promotional material bearing the mark, and any claims to registration;
• Misuse of the mark may be grounds for withdrawal of certification;
• Certificate holders shall abide by the requirements of the accreditation bodies and registrars that issued the certificates; and
• Products may be advertised as being produced using a TL 9000 registered quality management system.
The QuEST Forum establishes requirements for accreditation bodies to use in qualifying registrars. The Forum defines requirements that registrars must satisfy to
3.4 (Re) Qualifying 3.2 Migration Path
3.3 Publicizing Registration
Third-party registration is addressed in the Appendix, “Registration Procedures.”
Accredited registrars carry out registration of a supplier’s quality management system to TL 9000. Accreditation of registrars is the responsibility of accreditation bodies that are recognized by the QuEST Forum. An accreditation body is
responsible for examining registrar qualifications and processes to certify that they have adequately trained and experienced personnel, necessary organizational structure and procedure(s), and other attributes as stated in the Appendix, “Code of Practice for TL 9000 Registrars.” Contact the QuEST Forum Administrator for the list of recognized accreditation bodies.
Registrars are responsible for verifying that the suppliers, with whom they contract to provide registration to TL 9000, have implemented a quality management system that complies with TL 9000. This responsibility is ongoing as long as the registration contract is active. In carrying out this responsibility, registrars must comply with their own procedure(s), the requirements of their contracted registrar accreditation
body(ies), and with Appendix, “Code of Practice for TL 9000 Registrars”. A registrar must be fully recognized by an accreditation body that is recognized by the QuEST Forum. Contact the QuEST Forum Administrator for the list of TL 9000 accredited registrars.
The QuEST Forum is responsible for assuring the availability of appropriate training to help users correctly and consistently interpret and apply the TL 9000
requirements. All training providers that train registrars’ assessors must be approved by the QuEST Forum.
3.7 Training 3.5 Accreditation Bodies
Section 4 - Quality System Requirements
Management Responsibility - Element 4.1
Quality Policy 4.1.1
The supplier's management with executive responsibility shall define and document its policy for quality, including objectives for quality and its commitment to quality. The quality policy shall be relevant to the supplier's organizational goals and the expectations and needs of its customers. The supplier shall ensure that this policy is understood, implemented, and maintained at all levels of the organization.
4.1.1.C.1 Quality Objectives – Objectives for quality shall include targets for the
TL 9000 metrics defined in the TL 9000 Quality System Metrics handbook.
C-NOTE A: Management with executive responsibility should demonstrate their
active involvement in long- and short-term quality planning.
Organization 4.1.2
4.1.2.1 Responsibility and Authority - The responsibility, authority, and the
interrelation of personnel who manage, perform and verify work affecting quality shall be defined and documented, particularly for personnel who need the organizational freedom and authority to:
a) Initiate action to prevent the occurrence of any nonconformities relating to product, process and quality system;
b) Identify and record any problems relating to the product, process and quality system;
c) Initiate, recommend or provide solutions through designated channels; d) Verify the implementation of solutions;
e) Control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.
4.1.2.2 Resources - The supplier shall identify resource requirements and provide
adequate resources, including the assignment of trained personnel (see 4.18), for management, performance of work and verification activities including internal quality audits.
4.1.2.3 Management Representative - The supplier's management with executive
responsibility shall appoint a member of the supplier's own management who, irrespective of other responsibilities, shall have defined authority for
a) Ensuring that a quality system is established, implemented and maintained in accordance with this International Standard, and
b) Reporting on the performance of the quality system to the supplier's
management for review and as a basis for improvement of the quality system.
NOTE 5: The responsibility of a management representative may also include liaison
with external parties on matters relating to the supplier's quality system.
Management Review 4.1.3
The supplier's management with executive responsibility shall review the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of this International Standard and the supplier's stated quality policy and objectives (see 4.1.1). Records of such reviews shall be maintained (see 4.16).
Quality System - Element 4.2
General 4.2.1
The supplier shall establish, document, and maintain a quality system as a means of ensuring that product conforms to specified requirements. The supplier shall
prepare a quality manual covering the requirements of this International Standard. The quality manual shall include or make reference to the quality-system procedures and outline the structure of the documentation used in the quality system.
NOTE 6: Guidance on quality manuals is given in ISO 10013.
Quality System Procedures 4.2.2
The supplier shall:
a) Prepare documented procedures consistent with the requirements of this International Standard and the supplier's stated quality policy, and b) Effectively implement the quality system and its documented procedures. For the purposes of this International Standard, the range and detail of the procedures that form part of the quality system depend on the complexity of the work, the methods used and the skills and training needed by personnel involved in carrying out the activity.
NOTE 7: Documented procedures may make reference to work instructions that
define how an activity is performed.
4.2.2.C.1 Life Cycle Model - The supplier shall establish and maintain an integrated
set of guidelines that covers the life cycle of its products. This framework shall contain the processes, activities, and tasks involved in the development, operation, and maintenance and (if required) disposal of products, spanning the life of the products. [9]
4.2.2.S.1 Support Software and Tools Management - The supplier shall ensure
that internally developed support software and tools used in the product life cycle are subject to the appropriate quality method(s). Tools to be considered include: design and development tools, testing tools, configuration management tools, and
Quality Planning 4.2.3
The supplier shall define and document how the requirements for quality will be met. Quality planning shall be consistent with all other requirements of a supplier's quality system and shall be documented in a format to suit the supplier's method of
operation. The supplier shall give consideration to the following activities, as appropriate, in meeting the specified requirements for products, projects, or contracts:
a) The preparation of quality plans;
b) The identification and acquisition of any controls, processes, equipment
(including inspection and test equipment), fixtures, resources and skills that may be needed to achieve the required quality;
c) Ensuring the compatibility of the design, the production process, installation, servicing, inspection, and test procedures, and the applicable documentation; d) The updating, as necessary, of quality control, inspection, and testing
techniques, including the development of new instrumentation;
e) The identification of any measurement requirement involving capability that exceeds the known state of the art, in sufficient time for the needed capability to be developed;
f) The identification of suitable verification at appropriate stages in the realization of product;
g) The clarification of standards of acceptability for all features and requirements, including those which contain a subjective element;
h) The identification and preparation of quality records (see 4.16).
NOTE 8: The quality plans referred to (see 4.2.3a) may be in the form of a
reference to the appropriate documented procedures that form an integral part of the supplier’s quality system.
4.2.3.C.1 Customer Involvement - The supplier shall establish and maintain
methods for soliciting and considering customer input for quality planning activities. Consideration should be given to establishing joint customer-supplier quality improvement programs. [4]
4.2.3.C.2 Long- and Short-Term Planning - The supplier’s quality planning
activities shall include long- and short-term plans with goals for improving quality and customer satisfaction. These plans shall address:
a) Cycle time; b) Customer service; c) Training;
d) Cost;
e) Delivery commitments; and f) Product reliability.
4.2.3.C.3 Subcontractor Input - The supplier shall establish and maintain methods
for soliciting and using subcontractor input for quality planning activities. [4]
4.2.3.C.4 Disaster Recovery - The supplier shall establish and maintain methods
for disaster recovery to ensure the ability to recreate and service the product throughout its life cycle. [9]
Contract Review - Element 4.3
General 4.3.1
The supplier shall establish and maintain documented procedures for contract review and for the coordination of these activities.
Review 4.3.2
Before submission of a tender, or at the acceptance of a contract or order (statement of requirement), the tender, contract or order shall be reviewed by the supplier to ensure that:
a) The requirements are adequately defined and documented; where no written statement or requirement is available for an order received by verbal means, the supplier shall ensure that the order requirements are agreed before their
acceptance;
b) Any differences between the contract or accepted order requirements and those in the tender are resolved;
c) The supplier has the capability to meet the contract or accepted order requirements.
C-NOTE B: The contract review process should include:
a) Product acceptance planning and review;
b) Handling of problems detected after product acceptance, including customer complaints and claims; and
c) Responsibility of removal and/or correction of nonconformities after applicable warranty period or during product maintenance contract period. [8]
C-NOTE C: The product acceptance plan should include as appropriate:
a) Acceptance review process; b) Acceptance criteria;
c) Documented test procedure(s); d) Test environment;
e) Test cases; f) Test data;
g) Resources involved;
h) Method(s) for problem tracking and resolution; and i) Required acceptance test reports. [9]
Amendment to Contract 4.3.3
The supplier shall identify how an amendment to a contract is made and correctly transferred to the functions concerned within the supplier's organization.
Records 4.3.4
Records of contract reviews shall be maintained (see 4.16).
NOTE 9: Channels for communication and interfaces with the customer's
Design Control - Element 4.4
General 4.4.1
The supplier shall establish and maintain documented procedures to control and verify the design of the product in order to ensure that the specified requirements are met.
V-NOTE D: Design of Services – All design control requirements apply to suppliers
that are responsible for the design of delivered services.
4.4.1.C.1 Requirements Traceability - The supplier shall establish and maintain a
method to trace specified requirements through design and test. [10]
Design and Development Planning 4.4.2
The supplier shall prepare plans for each design and development activity. The plans shall describe or reference these activities, and define responsibility for their implementation. The design and development activities shall be assigned to qualified personnel equipped with adequate resources. The plans shall be updated, as the design evolves.
4.4.2.C.1 Project Plan - The supplier shall establish and maintain a project plan
based upon the defined product life cycle model. The plan should include: a) Project organizational structure;
b) Project roles and responsibilities;
c) Interfaces with internal and external organizations;
d) Means for scheduling, tracking, issue resolution, and reporting; e) Budgets, staffing, and schedules associated with project activities; f) Method(s), standards, documented procedure(s), and tools to be used; g) References to related plans (e.g., development, testing, configuration
management, and quality);
h) Project-specific environment and physical resource considerations (e.g., development, user documentation, testing, and operation);
i) Customer, user, and subcontractor involvement during the product life cycle (e.g., joint reviews, informal meetings, and approvals);
j) Management of project quality;
k) Risk management and contingency plans (e.g., technical, cost and schedules); l) Performance, safety, security, and other critical requirements;
m) Project-specific training requirements; n) Required certifications;
o) Proprietary, usage, ownership, warranty and licensing rights; and p) Post-project analysis. [9]
C-NOTE E: The project plan and any related plans may be an independent
C-NOTE F: General work instructions defining tasks and responsibilities common to
all development projects need not be replicated as part of a documented project plan.
4.4.2.C.2 Test Planning - Test plans shall be documented and results recorded.
Test plans should include:
a) Scope of testing (e.g., unit, feature, integration, system, acceptance); b) Types of tests to be performed (e.g., functional, boundary, usability,
performance, regression, interoperability); c) Traceability to requirements;
d) Test environment (e.g., relevancy to customer environment, operational use); e) Test coverage;
f) Expected results;
g) Data definition and database requirements;
h) Set of tests, test cases (inputs, outputs, test criteria), and documented test procedure(s); and
i) Use of external testing. [10]
C-NOTE G: Testing may be covered at several levels.
4.4.2.C.3 End of Life Planning - The supplier shall establish and maintain a
documented procedure(s) for the discontinuance of manufacturing and/or support of a product by the operation and service organizations. This documented
procedure(s) should include:
a) Cessation of full or partial support after a certain period of time; b) Archiving product documentation and software;
c) Responsibility for any future residual support issues; d) Transition to the new product, if applicable; and e) Accessibility of archive copies of data. [9]
4.4.2.S.1 Estimation - The supplier shall establish and maintain a method for
estimating and tracking project factors during project planning, execution, and change management. Project factors to be considered should include product size, complexity, effort, staffing, schedules, cost, quality, reliability, and productivity. [10]
4.4.2.S.2 Computer Resources - The supplier shall establish and maintain
methods for estimating and tracking critical computer resources for the target computer. Examples of these resources are utilization of memory, throughput, real time performance, and I/O channels. [10]
4.4.2.S.3 Integration Planning – The supplier shall develop and document a plan
to integrate the software components into the product. The plan shall include: a) Methods and documented procedure(s);
b) Responsibilities;
c) Schedule for integration; and d) Test requirements. [9]
4.4.2.S.4 Migration Planning - When a system or software product is planned to
be migrated from an old to a new environment, the supplier shall develop and document a migration plan. This plan should include the following:
a) Requirements analysis and definition of migration; b) Development of migration tools;
c) Conversion of product and data; d) Migration execution;
e) Migration verification; and
f) Support for the old environment in the future. [9]
Organizational and Technical Interfaces 4.4.3
Organizational and technical interfaces between different groups which input into the design process shall be defined and the necessary information documented,
transmitted, and regularly reviewed.
C-NOTE H: The supplier should establish communication methods for
dissemination of product requirements, and changes to requirements to all impacted parties identified in the project plan.
Design Input 4.4.4
Design-input requirements relating to the product, including applicable statutory and regulatory requirements, shall be identified, documented and their selection reviewed by the supplier for adequacy. Incomplete, ambiguous, or conflicting requirements shall be resolved with those responsible for imposing these requirements.
Design input shall take into consideration the results of any contract-review activities.
4.4.4.C.1 Customer and Subcontractor Input - The supplier shall establish and
maintain methods for soliciting and using customer and subcontractor input during the development of new or revised product requirements. [4]
4.4.4.C.2 Design Requirements - Design requirements shall be defined and
documented, and should include: a) Quality and reliability requirements; b) Functions and capabilities of the product;
c) Business, organizational, and user requirements; d) Safety, environmental, and security requirements; e) Installability, usability and maintainability requirements; f) Design constraints; and
g) Testing requirements. [9]
4.4.4.H.1 Content of Requirements - The design requirements shall include, but
are not limited to:
a) Nominal values and tolerances; b) Maintainability needs; and
4.4.4.S.1 Identification of Software Requirements - The supplier shall determine,
analyze, and document the software component requirements of the system.[9]
4.4.4.S.2 Requirements Allocation - The supplier shall document the allocation of
the product requirements to the product architecture.[8]
Design Output 4.4.5
Design output shall be documented and expressed in terms that can be verified against design-input requirements and validated (see 4.4.8).
Design output shall:
a) Meet the design-input requirements;
b) Contain or make reference to acceptance criteria;
c) Identify those characteristics of the design that are crucial to the safe and proper functioning of the product (e.g., operating, storage, handling, maintenance and disposal requirements).
Design-output documents shall be reviewed before release.
4.4.5.S.1 Design Output - The required output from the design activity shall be
defined and documented in accordance with the chosen method. Design outputs may include, but are not limited to:
a) Architectural design; b) Detailed design; c) Source code; and d) User documentation. [8]
4.4.5.V.1 Services Design Output - The required output from the services design
shall contain a complete and precise statement of the service to be provided. Design outputs shall include, but are not limited to:
a) Service delivery procedures; b) Resource and skill requirements; c) Reliance on sub-contractors;
d) Service characteristics subject to customer evaluation; and e) Standards of acceptability for each service characteristic.[12]
Design Review 4.4.6
At appropriate stages of design, formal documented reviews of the design results shall be planned and conducted. Participants at each design review shall include representatives of all functions concerned with the design stage being reviewed, as well as other specialist personnel, as required. Records of such reviews shall be maintained (see 4.16).
Design Verification 4.4.7
At appropriate stages of design, design verification shall be performed to ensure that the design-stage output meets the design-stage input requirements. The design-verification measures shall be recorded (see 4.16).
NOTE 10: In addition to conducting design reviews (see 4.4.6), design verification
may include activities such as:
• Performing alternative calculations,
• Comparing the new design with a similar proven design, if available,
• Undertaking tests and demonstrations, and
• Reviewing the design-stage documents before release.
C-NOTE I: See 4.10 for related requirements.
Design Validation 4.4.8
Design validation shall be performed to ensure that product conforms to defined user needs and/or requirements.
NOTE 11: Design validation follows successful design verification (see 4.4.7). NOTE 12: Validation is normally performed under defined operating conditions. NOTE 13: Validation is normally performed on the final product, but may be
necessary in earlier stages prior to product completion.
NOTE 14: Multiple validations may be performed if there are different intended uses.
HV-NOTE J: See 4.10 for related requirements.
C-NOTE K: It may be beneficial to include customers or a third party during various
validation stages.
4.4.8.H.1 Periodic Retesting - The supplier shall establish and maintain a
documented procedure(s) that ensures products are periodically retested to assess the product's ability to continue to meet design requirements. [5]
4.4.8.H.2 Content of Testing - The initial test and periodic retest shall be more
extensive than the routine quality control tests. The initial test shall include those that are contained in the customer and/or supplier product specifications and/or contracts. The results of these tests shall be documented (See 4.16). [5]
H-NOTE L: Product specifications may include environmental, vibration,
flammability, and operational stress type testing.
4.4.8.H.3 Frequency of Testing - The supplier shall establish and document the
frequency for test/periodic retest. When determining the test frequency, the supplier shall include the following:
a) Product complexity and service criticality;
b) Number of design, engineering and/or manufacturing changes made to the product and whether the change(s) affect form, fit, and/or function;
c) Changes to the manufacturing process; d) Manufacturing variations, (e.g., tooling wear);
e) Material and/or component substitutions and failure rates; and f) The field performance record of the product. [5]
Design Changes 4.4.9
All design changes and modifications shall be identified, documented, reviewed and approved by authorized personnel before their implementation.
4.4.9.C.1 Change Management Process - The supplier shall establish and
maintain a process to ensure that all requirements and design changes, which may arise at any time during the product life cycle, are managed in a systematic and timely manner and do not adversely affect quality and reliability. Management of changes should include:
a) Impact analysis; b) Planning; c) Implementation; d) Testing; e) Documentation; f) Communication; and g) Review and approval. [5]
4.4.9.C.2 Informing Customers - The supplier shall establish and maintain a
documented procedure(s) to ensure that customers are informed when design changes effect contractual commitments. [5]
4.4.9.H.1 Tracking of Changes - The supplier shall track design changes and shall
use the results to ensure that the product still fulfills its design intent. [5]
4.4.9.H.2 Component Changes - The supplier shall have adequate documented
procedure(s) in place to ensure that material or component substitutions or changes do not adversely affect product quality or performance.
H-NOTE M: These documented procedure(s) should include:
a) Functional testing; b) Qualification testing; c) Stress testing;
d) Approved parts listing; and/or e) Critical parts listing.
4.4.9.V.1 Tool Changes – The supplier shall have documented procedure(s) in
place to ensure that substitutions or changes to tools used in performing the service do not adversely affect the quality of the service.
Document and Data Control - Element 4.5
General 4.5.1
The supplier shall establish and maintain documented procedures to control all documents and data that relate to the requirements of this International Standard including, to the extent applicable, documents of external origin such as standards and customer drawings.
NOTE 15: Documents and data can be in the form of any type of media, such as
hard copy or electronic media.
4.5.1.S.1 Control of Customer-Supplied Documents and Data –The supplier
shall establish and maintain documented procedure(s) to control all customer-supplied documents and data (e.g., network architecture, topology, capacity, and database) if these documents and data influence the design, verification, validation, inspection and testing, or servicing the product.
Document and Data Approval and Issue
4.5.2
The documents and data shall be reviewed and approved for adequacy by authorized personnel prior to issue. A master list or equivalent document-control procedure identifying the current revision status of documents shall be established and be readily available to preclude the use of invalid and/or obsolete documents. This control shall ensure that:
a) The pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed;
b) Invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use;
c) Any obsolete documents retained for legal and/or knowledge-preservation purposes are suitably identified.
Document and Data Changes 4.5.3
Changes to documents and data shall be reviewed and approved by the same functions/organizations that performed the original review and approval, unless specifically designated otherwise. The designated functions/organizations shall have access to pertinent background information upon which to base their review and approval.
Where practicable, the nature of the change shall be identified in the document or the appropriate attachments.
Purchasing - Element 4.6
General 4.6.1
The supplier shall establish and maintain documented procedures to ensure that purchased product (see 3.1) conforms to specified requirements.
C-NOTE N: The reference to “(see 3.1)” above references ISO 9001:1994, which is
not included in this document.
4.6.1.C.1 Purchasing Procedure(s) - The documented purchasing procedure(s)
shall include:
a) Product requirements definition; b) Risk analysis and management; c) Qualification criteria;
d) Contract definition;
e) Proprietary, usage, ownership, warranty and licensing rights are satisfied; f) Future support for the product is planned;
g) Ongoing supply-base management and monitoring; h) Subcontractor selection criteria; and
i) Subcontractor re-evaluation;
j) Feedback to key subcontractors based on data analysis of subcontractor performance.[9]
C-NOTE O: This documented procedure(s) should be applicable to off-the-shelf
product. This typically includes original equipment manufacturer (OEM) products used in manufacturing and commercial off-the-shelf (COTS) products used in software systems.
Evaluation of Subcontractors 4.6.2
The supplier shall:
a) Evaluate and select subcontractors on the basis of their ability to meet
subcontract requirements including the quality system and any specific quality-assurance requirements;
b) Define the type and extent of control exercised by the supplier over
subcontractors. This shall be dependent upon the type of product, the impact of subcontracted product on the quality of final product, and where applicable, on the quality audit reports and/or quality records of the previously demonstrated capability and performance of subcontractors;
Purchasing Data 4.6.3
Purchasing documents shall contain data clearly describing the product ordered, including where applicable:
a) The type, class, grade or other precise identification;
b) The title or other positive identification, and applicable issues of specifications, drawings, process requirements, inspection instructions and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment, and personnel;
c) The title, number, and issue of the quality-system standard to be applied. The supplier shall review and approve purchasing documents for adequacy of the specified requirements prior to release.
Verification of Purchased Product 4.6.4
4.6.4.1 Supplier Verification at Subcontractor's Premises - Where the supplier
proposes to verify purchased product at the subcontractor's premises, the supplier shall specify verification arrangements and the method of product release in the purchasing documents.
4.6.4.2 Customer Verification of Subcontracted Product - Where specified in the
contract, the supplier's customer or the customer's representative shall be afforded the right to verify at the subcontractor's premises and the supplier's premises that subcontracted product conforms to specified requirements. Such verification shall not be used by the supplier as evidence of effective control of quality by the subcontractor.
Verification by the customer shall not absolve the supplier of the responsibility to provide acceptable product, nor shall it preclude subsequent rejection by the customer.
Control of Customer-Supplied Product - Element 4.7
The supplier shall establish and maintain documented procedures for the control of verification, storage, and maintenance of customer-supplied product provided for incorporation into the supplies or for related activities. Any such product that is lost, damaged, or is otherwise unsuitable for use shall be recorded and reported to the customer (see 4.16).
Verification by the supplier does not absolve the customer of the responsibility to provide acceptable product.
Product Identification and Traceability - Element 4.8
Where appropriate, the supplier shall establish and maintain documented procedures for identifying the product by suitable means from receipt and during all stages of production, delivery, and installation.
Where and to the extent that traceability is a specified requirement, the supplier shall establish and maintain documented procedures for unique identification of individual product or batches. This identification shall be recorded (see 4.16).
4.8.H.1 Traceability for Recall - Field Replaceable Units (FRU) shall be traceable
throughout the product life cycle in a way that helps suppliers and customers to identify products being recalled, needing to be replaced or modified.
4.8.H.2 Traceability of Design Changes – The supplier shall establish and
maintain documented procedure(s) which provide traceability of design changes to identifiable manufacturing dates, lots, or serial numbers.
4.8.HS.1 Configuration Management Plan - The supplier shall establish and
maintain a configuration management plan which should include: a) Identification and scope of the configuration management activities; b) Schedule for performing these activities;
c) Configuration management tools;
d) Configuration management methods and documented procedure(s); e) Organizations and responsibilities assigned to them;
f) Level of required control for each configuration item; and
g) Point at which items are brought under configuration management. [9]
HS-NOTE P: General work instructions defining general configuration management
tasks and responsibilities need not be replicated as part of a specific documented configuration management plan.
4.8.HS.2 Product Identification - The supplier shall establish and maintain a
process for the identification of each product and the level of required control. For each product and its versions, the following shall be identified as appropriate: a) Documentation;
b) Associated tools needed for product re-creation; c) Interfaces to other software and hardware; and d) Software and hardware environment. [8]
Process Control - Element 4.9
The supplier shall identify and plan the production, installation, and servicing processes which directly affect quality and shall ensure that these processes are carried out under controlled conditions. Controlled conditions shall include the following:
a) Documented procedures defining the manner of production, installation, and servicing, where the absence of such procedures could adversely affect quality; b) Use of suitable production, installation, and servicing equipment and a suitable
working environment;
c) Compliance with reference standards/codes, quality plans and/or documented procedures;
d) Monitoring and control of suitable process parameters and product characteristics;
e) The approval of processes and equipment, as appropriate;
f) Criteria for workmanship, which shall be stipulated in the clearest practical manner (e.g., written standards, representative samples or illustrations); g) Suitable maintenance of equipment to ensure continuing process capability. Where the results of processes cannot be fully verified by subsequent inspection and testing of the product and where, for example, processing deficiencies may become apparent only after the product is in use, the processes shall be carried out by qualified operators and/or shall require continuous monitoring and control of process parameters to ensure that the specified requirements are met.
The requirements for any qualification of process operations, including associated equipment and personnel (see 4.18), shall be specified.
NOTE 16: Such processes requiring pre-qualification of their process capability are
frequently referred to as special processes.
Records shall be maintained for qualified processes, equipment and personnel, as appropriate (see 4.16).
4.9.H.1 Inspection and Testing - Inspection and testing results shall be recorded
and analyzed for the purpose of identifying problem areas. [5]
4.9.HV.1 Operational Changes - Each time a significant change is made in the
established operation (e.g., a new operator, new machine, or new technique), a critical examination shall be made of the first unit(s)/service(s) processed after the change. [5]
demonstrated skills. The supplier shall communicate this information to all affected employees. [4]
4.9.HV.3 Employee Skills List - The supplier shall maintain records of employees
and their skills and qualifications (e.g., employee skills bank or training records) to aid in determination of work assignments. [4]
4.9.S.1 Replication - The supplier shall establish and maintain a documented
procedure(s) for replication which should include the following: a) Identification of the master copy and copies to be delivered; b) The number of copies to be delivered;
c) Type of media and associated labeling;
d) Identification and packaging of required documentation such as user manuals; and
e) Controlling the replication environment to ensure repeatability. [8]
4.9.S.2 Release Management – The supplier shall establish and maintain
documented procedure(s) to control the release and delivery of software products and documentation. These documented procedure(s) should include methods to provide for the following:
a) Release planning information delivered to the customer sufficiently in advance of the release;
b) Product introduction and release schedules to the customer;
c) Detailed descriptions of product features delivered, and changes incorporated in new software products or releases; and
d) Advising the customer of current or planned changes. [10]
4.9.V.1 Software Used in Service Delivery - Suppliers shall document and
implement processes for the maintenance and control of software used in service delivery to ensure continued process capability and integrity.
4.9.V.2 Service Delivery Plan – Suppliers that are responsible for the delivery or
implementation of a service, and are not responsible for the design of that service, shall comply with the Project Plan requirements of 4.4.2.C.1.
Inspection and Testing - Element 4.10
General 4.10.1
The supplier shall establish and maintain documented procedures for inspection and testing activities in order to verify that the specified requirements for the product are met. The required inspection and testing, and the records to be established, shall be detailed in the quality plan or documented procedures.
C-NOTE Q: See 4.4.7 and 4.4.8 for related requirements.
4.10.1.HV.1 Inspection and Test Documentation - Each inspection or testing
activity shall have detailed documentation. Details should include the following: a) Parameters to be checked with acceptable tolerances;
b) The use of statistical techniques, control charts, etc.;
c) Sampling plan, including frequency, sample size, and acceptance criteria; d) Handling of nonconformances;
e) Data to be recorded;
f) Defect classification scheme;
g) Method for designating an inspection item or lot; and h) Electrical, functional, and feature testing. [5]
4.10.1.S.1 Test Documentation - Software tests shall be conducted according to
documented procedure(s) and the test plan. Documentation of testing shall include: a) Test results;
b) Analysis of test results;
c) Conformance to expected results; and
d) Problem reporting for nonconforming items. [10]
Receiving Inspection and Testing
4.10.2
4.10.2.1 The supplier shall ensure that incoming product is not used or processed
(except in the circumstances described in 4.10.2.3) until it has been inspected or otherwise verified as conforming to specified requirements. Verification of the specified requirements shall be in accordance with the quality plan and/or documented procedures.
4.10.2.2 In determining the amount and nature of receiving inspection, consideration
shall be given to the amount of control exercised at the subcontractor's premises and the recorded evidence of conformance provided.
4.10.2.3 Where incoming product is released for urgent production purposes prior to
verification, it shall be positively identified and recorded (see 4.16) in order to permit immediate recall and replacement in the event of nonconformity to specified
requirements.
In Process Inspection and Testing
4.10.3
The supplier shall:
a) Inspect and test the product as required by the quality plan and/or documented procedures;
b) Hold product until the required inspection and tests have been completed or necessary reports have been received and verified, except when product is released under positive-recall procedures (see 4.10.2.3). Release under positive-recall procedures shall not preclude the activities outlined in 4.10.3a.
Final Inspection and Testing 4.10.4
The supplier shall carry out all final inspection and testing in accordance with the quality plan and/or documented procedures to complete the evidence of
conformance of the finished product to the specified requirements.
The quality plan and/or documented procedures for final inspection and testing shall require that all specified inspection and tests, including those specified either on receipt of product or in-process, have been carried out and that the results meet specified requirements.
No product shall be dispatched until all the activities specified in the quality plan and/or documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized.
4.10.4.H.1 Testing of Repair and Return Products - Repair and return products
shall be subjected to the same or equivalent documented final acceptance test procedure(s) as newly manufactured products.[5]
4.10.4.H.2 Packaging and Labeling Audit - The supplier shall include a packaging
and labeling audit in the quality plan or documented procedure(s). This may include, for example, marking, labeling, kiting, documentation, customer-specific marking, and correct quantities.
Inspection and Test Records 4.10.5
The supplier shall establish and maintain records which provide evidence that the product has been inspected and/or tested. These records shall show clearly whether the product has passed or failed the inspections and/or tests according to defined acceptance criteria. Where the product fails to pass any inspections and/or test, the procedures for control of nonconforming product shall apply (see 4.13). Records shall identify the inspection authority responsible for the release of product (see 4.16).
4.10.5.HV.1 Inspection and Test Records - Inspection and test records shall
include:
a) Product identification;
b) Quantity of product inspected;
c) Documented inspection procedure(s) followed; d) Person performing the test and inspection; e) Date of inspection and/or test; and
Control of Inspection, Measuring, and Test Equipment - Element 4.11
General 4.11.1
The supplier shall establish and maintain documented procedures to control, calibrate, and maintain inspection, measuring, and test equipment (including test software) used by the supplier to demonstrate the conformance of product to the specified requirements. Inspection, measuring, and test equipment shall be used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability.
Where test software or comparative references such as test hardware are used as suitable forms of inspection, they shall be checked to prove that they are capable of verifying the acceptability of product, prior to release for use during production, installation, or servicing, and shall be rechecked at prescribed intervals. The supplier shall establish the extent and frequency of such checks and shall maintain records as evidence of control (see 4.16).
Where the availability of technical data pertaining to the measurement equipment is a specified requirement, such data shall be made available, when required by the customer or customer's representative, for verification that the measuring equipment is functionally adequate.
NOTE 17: For the purposes of this International Standard, the term "measuring
equipment" includes measurement devices.
Control Procedure 4.11.2
The supplier shall:
a) Determine the measurements to be made and the accuracy required, and select the appropriate inspection, measuring, and test equipment that is capable of the necessary accuracy and precision;
b) Identify all inspection, measuring, and test equipment that can affect product quality, and calibrate and adjust them at prescribed intervals, or prior to use, against certified equipment having a known valid relationship to internationally or nationally recognized standards. Where no such standards exist, the basis used for calibration shall be documented;
c) Define the process employed for the calibration of inspection, measuring, and test equipment, including details of equipment type, unique identification,
location, frequency of checks, check method, acceptance criteria, and the action to be taken when results are unsatisfactory;
d) Identify inspection, measuring, and test equipment with a suitable indicator or approved identification record to show the calibration status;
e) Maintain calibration records for inspection, measuring, and test equipment (see 4.16);
